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NEWARK, Calif.--(BUSINESS WIRE)--Dec. 4, 2018--
Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company
developing next-generation neuromodulators for use in treating aesthetic
and therapeutic conditions, today announced its long-acting
neuromodulator DaxibotulinumtoxinA for Injection (RT002) with its
proprietary stabilizing excipient peptide technology delivered positive
top-line results in alleviating moderate-to-severe glabellar (frown)
lines in the SAKURA 3 Phase 3 open-label, long-term safety study.
Completion of this study paves the way for Revance to submit a Biologics
License Application (BLA) with the U.S. Food and Drug Administration
(FDA), which is on-track for the first half of 2019.

As a component of the largest clinical program of an aesthetic
neuromodulator, the SAKURA 3 study included nearly 2,700 patients and
more than 3,800 treatments. Patients received up to three treatments of
RT002 and were followed for over a year and a half. Overall, the safety
findings were consistent with the known safety profiles for currently
available neuromodulators in aesthetics. Importantly, the rate of
treatment-related adverse events decreased over successive treatments.
For efficacy, based on investigator assessment, more than 95% of
patients achieved a score of none or mild glabellar lines at maximum
frown at Week 4 after each of three treatments. Measuring duration of
effect, the median time to return to baseline glabellar line severity
was 28 weeks. The median time to loss of none or mild wrinkle severity
was 24 weeks. The SAKURA 3 results were consistent with those in the
Phase 3 pivotal trials, SAKURA 1 and SAKURA 2.

“The results of this trial are exceptional since they demonstrate that
RT002 has consistently and predictably produced long duration and high
response rates and was well tolerated over successive treatments,” said
SAKURA investigator Jean D. Carruthers, M.D., who has served as an
investigator for multiple FDA-approved neuromodulators, and is a
clinical professor at the University of British Columbia. “My study
patients were thrilled with their appearance and the longevity RT002
delivered, and they can’t wait for this treatment option. I look forward
to the possibility of providing my patients a new, unique neuromodulator
that needs just two or fewer treatments a year.”

Dan Browne, co-founder, president and chief executive officer of Revance
said, “We are very excited by these compelling new data, which support
RT002 as a next-generation neuromodulator with highly differentiated
characteristics. We look forward to working closely with the FDA to
bring this important treatment to patients as soon as possible. The
success of the SAKURA aesthetic trials, combined with our ongoing
therapeutic studies in multiple neuroscience indications, drive our
mission to become the leading innovator in neuromodulators.”

Following these results, Revance today announced it will begin studies
in 2019 in forehead and lateral canthal lines (crow’s feet) to explore
the use and dosage of RT002 in the upper face.

“The long-term results in these studies, which are consistent and
predictable across age groups and prior toxin experience, are extremely
impressive,” said SAKURA investigator Steven Fagien, M.D., FACS,
Aesthetic Eyelid Plastic Surgery, Boca Raton, Florida, and one of the
world’s foremost experts in injectable neuromodulators. “The SAKURA data
demonstrate RT002 provides a trifecta of results – a reassuring safety
profile, high patient response rates, and long-lasting results. RT002
has the potential to raise the bar of expectations for neuromodulators
in the injectable facial aesthetic landscape.”

Global sales of neuromodulators totaled $4 billion in 2017 and are
estimated to nearly double by 2025. Despite this, market penetration has
remained below 10 percent for decades, at least in part because
currently available short-acting neuromodulators do not address the
number one desire of patients and physicians for longer-lasting results.

According to findings from a proprietary landmark survey of more than
2,000 women aged 25-70 conducted on behalf of Revance by The Harris
Poll,* facial lines and wrinkles are the most concerning visible sign of
aging among women in this age range. Still, only seven percent of women
said they have used a neuromodulator in the past five years. In
addition, the survey also included 246 dermatologists and plastic
surgeons who see at least 15 patients a week who receive neuromodulator
treatments. Among this group of physicians, 86 percent wish there was a
neuromodulator that offered longer-lasting results than what is
currently available.

SAKURA 3 TOP-LINE RESULTS

The SAKURA program targeted enrollment of at least 2,600 patients to
receive at least one treatment and 500 to receive three treatments with
RT002. The topline results include data from 2,691 subjects with
moderate-to-severe glabellar lines who were treated with RT002 (40U);
2,380 patients received Treatment #1, 882 patients received Treatment
#2, and 568 patients received all three treatments. In general, results
across safety, efficacy and duration measures were consistent and
predictable across age groups and prior toxin experience.

SAFETY

RT002 appeared to be generally well-tolerated, with no new tolerability
or safety concerns reported. As was seen in the SAKURA 1 and SAKURA 2
pivotal trials, adverse events were mild, localized and transient. The
rate of treatment-related adverse events decreased over successive
treatments. The most common treatment-related adverse events per
treatment of RT002 were headache (3.3 percent of treatments), injection
site pain (2.7 percent) and injection site erythema (2.5 percent). There
were no treatment-related serious adverse events. Eyelid ptosis was
reported in 0.9 percent of treatments, decreased in frequency with
successive treatments and was substantially lower than the rate observed
in SAKURA 1 and SAKURA 2 (2.2 percent). The majority of ptosis events
were characterized as mild in severity (85 percent) and transient.

EFFICACY

A high degree of efficacy was seen consistently across all three
treatment cycles. Results were consistent with SAKURA 1 and SAKURA 2
based on the Investigator Global Assessment-Facial Wrinkle Severity
(IGA-FWS) and Patient Facial Wrinkle Severity (PFWS) scales. As early as
Week 1, over 90 percent of subjects across all three treatments had none
or mild wrinkles.

At Week 4, the none or mild response rates as assessed by IGA-FWS were:

As in the SAKURA 1 and SAKURA 2 pivotal trials, there were several
secondary endpoints used to evaluate duration of effect, including
median time to loss of none or mild wrinkle severity on both IGA-FWS and
PFWS, and median duration for time to return to baseline wrinkle
severity on both IGA-FWS and PFWS. Duration was evaluated in the first
two 36-week treatment cycles; the third treatment cycle was not
evaluated for duration as the observation period ended at twelve weeks
for the purpose of this study.

Median time to return to baseline wrinkle severity on both IGA-FWS and
PFWS:

SAKURA 3: First treatment 28.0 weeks; second treatment 28.1 weeks

SAKURA 1: 27.7 weeks

SAKURA 2: 26.0 weeks

Median time to loss of none or mild wrinkle severity on both IGA-FWS and
PFWS:

SAKURA 3: First treatment 24.0 weeks; second treatment 24.1 weeks

SAKURA 1: 24.0 weeks

SAKURA 2: 23.9 weeks

About SAKURA Phase 3 Clinical Program

The SAKURA Phase 3 clinical program is the largest-ever aesthetic
neuromodulator clinical program, including nearly 2,800 patients who
received, in total, more than 4,200 treatments with RT002.

The SAKURA program included SAKURA 1 and SAKURA 2 – two randomized,
double-blind, placebo-controlled pivotal trials that were identical in
design to evaluate the safety and efficacy of a single administration of
RT002 for the treatment of moderate-to-severe glabellar lines in adults
from 18 to 75 years of age --and SAKURA 3, an open-label trial designed
to evaluate the long-term safety of RT002 in glabellar lines following
both single and repeat treatment administration in adults 18 years and
older. The SAKURA 1 and SAKURA 2 trials enrolled a total of 609 patients
at 30 sites in the U.S. and Canada. In these trials, patients were
randomized 2:1 to receive either RT002 (40U) or placebo. Post-treatment,
patients were followed for at least 24 weeks, at which time they were
eligible to roll-over into SAKURA 3.

The SAKURA 3 long-term safety trial enrolled 2,691 patients at 66 sites
in the U.S. and Canada. In SAKURA 3, patients were eligible to receive
up to three treatments and were followed for up to 84 weeks. Subjects
were eligible to be followed for up to 36 weeks after both treatments 1
and 2 and for up to 12 weeks after treatment 3.

About Glabellar Lines

The glabella is the area between the eyebrows and above the nose.
Glabellar lines, often called “frown lines,” are vertical lines that
develop between the eyebrows and may appear as a single vertical line or
as two or more lines. When you frown, the muscles of the glabella
contract causing vertical creases to form between the eyebrows.
Botulinum toxin is used to temporarily block the ability of nerves to
trigger contraction of injected muscle, inhibiting movement of the
muscles that cause the frown lines, giving the skin a smoother, more
refreshed appearance.

Based on data from Global Industry Analysts, Inc., the global market for
aesthetic treatments with neuromodulators represented about $1.6 billion
in revenue in 2016, and according to the American Society for Aesthetic
Plastic Surgery, botulinum toxin treatment is the No.1 nonsurgical
cosmetic procedure in the U.S. Management estimates glabellar line
treatment represents nearly $1 billion of the global market.

About RT002

DaxibotulinumtoxinA for Injection (RT002) is an investigational product
and the first neuromodulator with long-lasting duration. It is a novel,
next-generation neuromodulator in development for the treatment of
aesthetic indications and a number of potential therapeutic conditions,
including movement disorders, pain and other neuroscience-based targets.
RT002 is the only neuromodulator using a Revance proprietary stabilizing
excipient peptide technology in its formulation, which results in high
efficacy, long duration and provides two-year product stability
requiring no refrigeration. RT002 is the first and only botulinum toxin
product sourced, processed and manufactured in the U.S. and formulated
without human blood-derived products or manufactured using
animal-derived proteins.

Revance has four active clinical programs for RT002 injectable under
way. The SAKURA 1, SAKURA 2 and SAKURA 3 trials to treat glabellar lines
are complete. For cervical dystonia, the company was granted orphan drug
designation from the FDA and initiated a Phase 3 program in mid-2018.
The company plans to announce first patient dosing for Phase 2 trials
for RT002 for the management of plantar fasciitis and for adult upper
limb spasticity before year-end 2018.

Conference Call

Individuals interested in listening to the conference call may do so by
dialing (855) 453-3827 for domestic callers, or (484) 756-4301 for
international callers and reference conference ID: 2281019; or from the
webcast link in the investor relations section of the company's website
at: www.revance.com.

A replay of the call will be available beginning December 4, 2018
at 8:30am PT/11:30am ET to December 5, 2018 at 8:30am PT/11:30am ET. To
access the replay, dial (855) 859-2056 or (404) 537-3406 and reference
conference ID: 2281019. The webcast will be available in the investor
relations section on the company's website for 30 days following the
completion of the call.

About Revance Therapeutics, Inc.

Revance Therapeutics is an emerging Silicon Valley biotechnology leader
developing neuromodulators for the treatment of aesthetic and
therapeutic conditions. Revance uses a unique proprietary, stabilizing
excipient peptide technology to create novel, differentiated therapies.
The company’s lead compound, DaxibotulinumtoxinA for Injection (RT002),
is in clinical development for a broad range of aesthetic and
therapeutic indications, including glabellar lines, cervical dystonia,
plantar fasciitis, upper limb spasticity and chronic migraine. RT002 has
the potential to be the first long-acting neuromodulator. The company is
advancing a robust pipeline of injectable and topical formulations of
daxibotulinumtoxinA. More information on Revance may be found at www.revance.com.

“Revance Therapeutics” and the Revance logo are registered trademarks of
Revance Therapeutics, Inc.

*Method Statement -This survey was conducted online by The Harris Poll
on behalf of Revance among women aged 25-70 and Dermatologists and
Plastic Surgeons who see patients who receive neuromodulator treatments
in the United States. The consumer survey was conducted July 11 through
July 30, 2018 among 1,004 women ages 25-70 who have used a
Neuromodulator in the past 5 years and 1,005 women ages 25-70 who have
either never used a Neuromodulator, or have used one 5+ years ago.
Figures for age by gender, education, income, race/ethnicity, region,
size of household, marital status, and employment status were weighted
where necessary to bring them into line with their actual proportions in
the population. The healthcare professional survey was conducted July 31
through August 29, 2018 among 141 Dermatologists and 105 Plastic
Surgeons who see at least 15 patients per week who receive a
Neuromodulator treatment. Results were weighted for gender by years in
practice and region where necessary to bring them into line with their
actual proportions in the population.

Forward-Looking Statements

This press release contains forward-looking statements, including
statements related to Revance Therapeutics' current and anticipated
future clinical development of our investigational drug product
candidates, theinitiation, design, timing and results of our
clinical studies, including the SAKURA 3 study of RT002, and related
reporting of such results; the timing for the Phase 2 trials for RT002
for the management of plantar fasciitis and for adult upper limb
spasticity; statements about our business strategy, timeline and other
goals and market for our anticipated products, plans and prospects;
including our pre-commercialization plans and timing of our potential
BLA submission for RT002 to treat glabellar (frown) lines and
commercial potential of our client candidates; and statements about our
ability to obtain regulatory approval with respect to our drug; and
potential benefits of our drug product candidates and our excipient
peptide and other technologies.

Forward-looking statements are subject to risks and uncertainties
that could cause actual results to differ materially from our
expectations. These risks and uncertainties include, but are not limited
to: the outcome, cost, and timing of our product development activities
and clinical trials; the uncertain clinical development process,
including the risk that clinical trials may not have an effective design
or generate positive results, or that positive results would assure
regulatory approval or commercial success of our product candidates; our
ability to obtain and maintain regulatory approval of our drug product
candidates; our ability to obtain funding for our operations; our plans
to research, develop, and commercialize our drug product candidates; our
ability to achieve market acceptance of our drug product candidates;
unanticipated costs or delays in research, development, and
commercialization efforts; the applicability of clinical study results
to actual outcomes; the size and growth potential of the markets for our
drug product candidates; our ability to successfully commercialize our
drug product candidates and the timing of commercialization activities;
the rate and degree of market acceptance of our drug product candidates;
our ability to develop sales and marketing capabilities; the accuracy of
our estimates regarding expenses, future revenues, capital requirements
and needs for financing; our ability to continue obtaining and
maintaining intellectual property protection for our drug product
candidates; and other risks. Detailed information regarding factors that
may cause actual results to differ materially from the results expressed
or implied by statements in this press release may be found in Revance's
periodic filings with the Securities and Exchange Commission (the
"SEC"), including factors described in the section entitled "Risk
Factors" of our quarterly report on Form 10-Q filed November 2, 2018.
These forward-looking statements speak only as of the date hereof.
Revance disclaims any obligation to update these forward-looking
statements.